Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus

NCT ID: NCT02920060

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-08-31

Brief Summary

This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion. Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus.

Detailed Description

In our study patients were considered to have RSE if children were still having active convulsions despite receiving injection lorazepam intravenously at a dose of 0.1 mg/kg (max 4 mg) at a rate maximum upto 2 mg/min or intravenous diazepam at a dose of 0.2 - 0.3 mg/Kg (maximum 10 mg) slowly or intravenous midazolam at a dose of 0.15 - 0.2 mg/kg(max 5 mg). In case of children with difficult intravenous access buccal/nasal midazolam 0.2 - 0.3 mg/kg (maximum 5 mg) per rectal diazepam 0.5 mg/kg (maximum 10 mg) or intramuscular midazolam 0.2 mg/kg (maximum 5 mg). If seizure continued at 5 minutes, a repeat dose of benzodiazepine was given with same dose. At 10 minutes, if the seizure activity still remains intravenous phenytoin was given at a dose of 20mg/kg(maximum- 1000mg) at a rate of 1mg/kg/minute or intravenous fosphenytoin at 20mg PE/kg (if available) at a rate of 3mg PE/kg/minute.

Patients having seizure activity despite administration of above medications were considered to have RSE. Out of thousands of patients seen in outdoor and emergency ward, 80 patients were diagnosed to have RSE and met the inclusion criteria. After counselling the parents/guardians about the medications and obtaining a written informed consent they were randomized to into two groups : sodium valproate(V) and levetiracetam group(L), using a computer generated randomization chart. Forty patients in group V received intravenous valproic acid in dose of 20 mg/kg as loading dose at a rate of 40 mg/min after dilution with normal saline followed by maintenance dose of 10mg/kg/dose 8 hourly. In group L patients received intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min followed by 20mg/kg/dose 12 hourly.

Conditions

Grand Mal Status Epilepticus

Keywords

RSE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam

patient in this group will receive intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min

Group Type: EXPERIMENTAL

Intravenous levetiracetam

Intervention Type: DRUG

intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).

Sodium valproate

patients in this group will receive intravenous sodium valproate 20 mg/kg as loading dose at a rate of 40 mg/min

Group Type: ACTIVE_COMPARATOR

Sodium valproate

Intervention Type: DRUG

intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)

Interventions

Intravenous levetiracetam

intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).

Intervention Type: DRUG

Sodium valproate

intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)

Intervention Type: DRUG

Other Intervention Names

injection Levera; injection Encorate

Eligibility Criteria

Inclusion Criteria

1. Age - 1 year to 16 years

2. Gender - male and female both

3. Refractory generalized convulsive status epilepticus i.e. not responding to any two of the first line drugs

Exclusion Criteria

1. Patients with epilepsia partialis continua.

2. Patients with definite history of any allergic reaction to intravenous levetiracetam or intravenous valproate, or any contraindications in giving these drugs.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Medical Sciences of the Banaras Hindu University, India

OTHER

Sponsor Role: collaborator

Banaras Hindu University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Astha Panghal

Pricipal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajniti Prasad, MD

Role: STUDY_DIRECTOR

Banaras Hindu University

Other Identifiers

ECR/526/Inst/UP/2014

Identifier Type: -

Identifier Source: org_study_id